# K061359: Denshield Treatment for Sensitive Teeth

- Pathway: 510(k) (Traditional)
- Applicant: Novamin Technology, Inc.
- Decided: Oct 18, 2006 after 155 days
- Product code: LBH (Varnish, Cavity)
- Device class: 2
- Regulation: 21 CFR 872.3260
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
DenShield TM is intended for the rapid and continual relief of hypersensitivity associated with exposed tooth dentin. Studies have shown that DenShield is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.

Source page: https://510kreport.com/device/K061359
Methodology: https://510kreport.com/methodology